Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 53

Below is a list of medical devices and their corresponding complexity (CLIA WAIVED, MODERATE, or HIGH) when testing for Glucose monitoring devices (FDA cleared/home use). Note that there may be additional pages of medical devices which test for Glucose monitoring devices (FDA cleared/home use) to choose from located at the bottom of the list.

Medical Device – Page 53COMPLEXITY
Tyson Bioresearch, Inc., TysonBio TB100 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
TysonBio AC500 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
TysonBio AC500 Pro Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
TysonBio AC800 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
TysonBio AC800 Pro Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
U.S. Diagnostics Inc. ACURA Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. EASYGLUCO Blood Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. EASYGLUCO Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. EasyGluco Plus Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. Freedom Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. G4 Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. Infinity Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. Maxima Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc. VERASENS Voice Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
US Diagnostics, Inc., VersSens Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
VALU-RITE BLOOD GLUCOSE SYSTEM
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
Vertex Diagnostics, UltraTRAK COMPLETE Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED
VIP Diagnostics LLC EZ Smart Blood Glucose Monitoring System
Analyte: Glucose monitoring devices (FDA cleared/home use)
CLIA WAIVED


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